Assessment of Novel Intraocular Injection Guide
1 other identifier
interventional
50
1 country
1
Brief Summary
To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 9, 2014
CompletedFirst Posted
Study publicly available on registry
December 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedResults Posted
Study results publicly available
May 5, 2021
CompletedMay 5, 2021
May 1, 2021
4 months
December 9, 2014
September 18, 2020
May 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale (VAS)
The VAS is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The scale scores range from 0mm (no pain) to 100mm (very severe pain). The patient marks on the line the point that they feel represents their perception of their current state (no pain to very severe pain).
one time for about 30 sec or less
Study Arms (2)
intraocular injection guide
EXPERIMENTALnovel intraocular injection guide is a long, tubular structure consisting of a non-moldable material with a single internal opening. There is a 2x2 square hole located at the bottom of the device where the needle exits the guide and enters the eye
standard lid speculum
ACTIVE COMPARATORStandard wire eyelid speculum
Interventions
The device is 35mm long with tapered edges for an easy grip and it aligns with the curvature of the cornea to ensure that needle entry takes place at the optimal distance for injection
Eligibility Criteria
You may qualify if:
- Subjects must be receiving bilateral injections of the same dose of vascular endothelial growth factor (VEGF) inhibitor
- Injections in both eyes must be given on the same day
- Male or female age 18 years or older
You may not qualify if:
- Any condition or reason that precludes the subject's ability to comply with the study -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raj K Maturi MD PC
Indianapolis, Indiana, 46290, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is a small one event study (about 10 min duration). The participant evaluates which speculum (used for about 30 sec or less) during the procedure provides better comfort. Thus, long term evaluation has not been peformed.
Results Point of Contact
- Title
- Raj K Maturi MD
- Organization
- Raj K M
Study Officials
- PRINCIPAL INVESTIGATOR
Raj K Maturi, MD
Raj K. Maturi, MD, PC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
December 9, 2014
First Posted
December 11, 2014
Study Start
September 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
May 5, 2021
Results First Posted
May 5, 2021
Record last verified: 2021-05